BEUDAMED
    FDA Adverse Event Summary report: N

    GLUCOFILM BLOOD GLUCOSE TEST STRIP

    MDR report key: 11450 · Received February 11, 1994

    Report

    Report Number
    MW1000731
    Date Received
    February 11, 1994
    Date of Event
    January 25, 1994
    Report Date
    February 3, 1994
    Manufacturer
    MILES LABORATORIES DIV. MILES, INC.
    Product Code
    CFR
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NURSING UNIT AND LAB REPORTED INACCURACY IN THE TEST STRIPS. 'ERR' MESSAGE WAS APPEARING IN THE MACHINES. NEW LOT NUMBER PROG #2 AND EXP 9/95 USED ON SAME MACHINES. NO PROBLEM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOFILM BLOOD GLUCOSE TEST STRIP CFR MILES LABORATORIES DIV. MILES, INC. E3189083

    Patients

    Seq Age Sex Outcome Treatment
    1 *